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Not yet recruitingPhase 1 / Phase 2

Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)

NCT07247370 · KET-DUAL · South West Sydney Local Health District

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

To assess the safety, feasibility and preliminary efficacy of ketamine-enhanced therapy (KET) for alcohol use disorder (AUD) and comorbid major depressive disorder (MDD) in an open-label, single arm, pilot clinical trial.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility will be assessed through recruitment rates, retention to follow-up, session attendance, and treatment adherence.

    Measured over 22 weeks

  • Safety will be assessed through the frequency, severity, and relatedness of adverse events (AEs), including dissociation, affective destabilisation, and vital sign abnormalities.

    Measured over 22 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Moderate to severe AUD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria 2. Presence of current Major Depressive Disorder (MDD), according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria 3. Expressed motivation to reduce or cease alcohol consumption. 4. Consumed at least 21 standard drinks per week or 2 HDD per week (≥5 standard drinks/day for men; ≥4 for women) in the month prior to screening 5. Age 18-70 6. Adequate cognition and English language skills to give valid consent and complete research interviews 7. Stable housing 8. Willingness to give written informed consent. 9. Willingness to comply with study procedures and attend scheduled visits. Exclusion Criteria: 1. DSM-5 diagnosis of current or past psychotic disorder, bipolar I disorder, or substance-induced psychosis. 2. Current acute suicidality, defined as high risk by the Columbia Suicide Severity Rating Scale (C-SSRS) or clinical judgment or attempts in the past 6 months. 3. DSM-5 diagnosis of current or past moderate-to-severe ketamine or other dissociative drug use disorder. 4. Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks. 5. Enrolment in another interventional clinical trial that may interfere with safety, data quality, or trial participation. 6. Pregnant or breastfeeding, or planning to become pregnant during the course of the study. 7. Significant uncontrolled medical conditions, including but not limited to: * Severe or poorly controlled hypertension (\>160/100 mmHg) * Severe cardiovascular disease (e.g., heart failure, recent myocardial infarction, dysrhythmia) * History of stroke, cerebral trauma, or intracranial mass/haemorrhage * Severe hepatic impairment (e.g., MELD ≥10) or end-stage liver disease, bladder or kidney disease 8. Clinically significant alcohol withdrawal at screening (e.g., CIWA-Ar ≥10, history of delirium tremens). 9. History of heightened intracranial pressure, seizures, or diagnosed seizure disorder (except childhood febrile seizures). 10. Known hypersensitivity to ketamine or any excipients. 11. Concurrent use of psychotropic medications (other than stable-dose antidepressants ≥4 weeks). 12. Active substance use disorder (moderate or severe) other than nicotine or caffeine; stable opioid use disorder permitted if on maintenance therapy (with strict stability criteria). 13. Inability or unwillingness to comply with study procedures, judged by the principal investigator. 14. Any clinically significant medical or psychiatric condition that, in the judgment of the Principal Investigator, poses a safety risk or could confound study results or hinder protocol adherence.

Where

1 study site

FacilityCityRegionCountry
Drug Health Services, Royal Prince Alfred HospitalSydneyNew South WalesAustralia

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07247370 on ClinicalTrials.gov →

Last updated in the registry 2025-11-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits